Device for storing and dispensing flowable compositions

ABSTRACT

The invention relates to a device for storing and dispensing a flowable composition. Said device comprises a first ( 1 ) and a second film ( 2 ), a dispensing zone ( 4 ), a first chamber  5 ), containing a first substance (A) and a second chamber ( 6 ), containing a second substance (B). Said chambers are interconnected by a transition zone ( 3 ) that can be selectively opened. At least one of the films is deep-drawn in the region of the chambers and at least one of the films is pre-formed in the region of the second chamber, in such a way that once the device has been activated by opening the transition zone, the first substance can to a great extent by completely transferred to the second chamber, increasing the volume of said chamber as a result.

[0001] The invention relates to a device for storing and dispensing acomposition of least two components which is capable of flowing aftermixing.

[0002] Small amounts of liquid can be stored and dispensed inreceptacles in the form of blister packs. In the thermoformed part ofthe pack closed off by a removable film there are formed, for example,two recesses which are separate from each other. The first recess maycontain a small amount of liquid, and a brush may be placed in the otherrecess.

[0003] WO-96/03326 describes, for example, a disposable receptacle whichhas depressions for storing a medicament and an applicator. Bothdepressions are protected from contamination by means of a peelablecovering film. In one embodiment, by pressing on the depressioncontaining the medicament, said medicament is transferred into thedepression containing the applicator in order to wet the applicator. Itis explained that this is possible only when the covering film is notbonded to the receptacle in the transition zone between the twodepressions.

[0004] U.S. Pat. No. 3,835,834 discloses a treatment kit which has twodepressions in a main body, which contain a care substance on the onehand and a swab on the other hand. The main body containing the caresubstance and the swab is protected from contamination by means of asealing film.

[0005] EP 0 895 943 A discloses a device for storing and dispensing aflowable substance, with a container made up of two films which areconnected to each other to form two chambers for receiving substancesand a pocket which is separate from the chambers and is used forremoving the mixture of the two substances, the separation between onechamber and the pocket having a transition zone that can be selectivelyopened. For activating the device, firstly pressure is exerted on onechamber, whereby the substance located in it is transferred into thesecond chamber via the transition zone. As a result, a positive pressurebuilds up in the second chamber and leads to bulging of one of the filmsforming the chambers. To prevent the mixture from flowing back into thefirst chamber, it is necessary for the device to be bent in the zonebetween the two chambers. This does not eliminate the possibility ofoperator errors.

[0006] It is consequently a disadvantage of the devices known from theprior art that they are only suitable with reservations for dispensinghomogeneous compositions which can be obtained by mixing two substancesstored separately in the device. In particular in the case ofcompositions with different volumes or states of aggregation of theirindividual constituents, a homogeneous and reproducible mixing resultoften cannot be ensured.

[0007] The prime object of the present invention is to provide animproved device for storing and dispensing mixtures.

[0008] A further object can be regarded as that of providing a devicewhich makes it possible for even relatively large amounts of substanceto be stored and dispensed without impairing the mixing result.

[0009] A further object can be regarded as that of providing amulti-chamber device which to a great extent prevents the mixture to bedispensed from flowing back into one of the chambers of the deviceduring dispensing.

[0010] These objects are achieved by providing a device such as thatdescribed in the claims.

[0011] The terms “comprise” or “include” introduce a list of featureswhich is not considered to be exhaustive. The fact that the word “a” isused in the claims before stating a feature does not exclude thepossibility that the features stated may be present as a plurality, inthe sense of “at least one”.

[0012] The device makes it possible to store, mix and dispense flowablecompositions of which the individual constituents can be storedseparately from one another in the device before mixing. The device isactivated by pressure being exerted on the first chamber, whereby thesubstance located in this chamber is transferred into the second chambervia the transition zone that can be selectively opened. The transitionzone that can be selectively opened consequently represents, as it were,a kind of predetermined breaking point.

[0013] The mixing of the two substances takes place in the secondchamber, in which the second substance is located.

[0014] If, by reason of its volume, the second chamber cannot receivethe first substance, or only under more difficult conditions, as in thedevice according to EP 0 895 943 A, only part of the first substance canbe mixed with the second substance. This is disadvantageous, since areproducible mixing result is required, in particular in the medicalsector. Mixtures with deviations in the concentration of individualconstituents are in many cases unusable.

[0015] The present invention solves this problem, since, according tothe invention, the second chamber is designed in such a way that it canreceive not only a first substance but also a second substance, it beingpossible for the two substances to be mixed in the device without thedevice having to be opened beforehand, but opening being possiblewithout any problem after mixing.

[0016] This is ensured by the volume of the second chamber constantlyallowing itself to increase.

[0017] For this purpose, the at least one of the films forming thechambers of the device is pre-formed or plastically deformable in thezone of the second chamber.

[0018] The device according to the invention also makes it possible tofollow the activation of the device by exerting pressure on the firstchamber, in particular visually. The transfer of the first substancefrom the first chamber into the second chamber brings about a permanentincrease in volume of the second chamber, which can be detected fromoutside during use.

[0019] The term “pre-formed” in the sense of the invention is to beunderstood as meaning a plastic, defined deforming or pre-forming of afilm, it being possible for the film to be converted from this form intoanother form in a controlled and deliberate manner. This includespre-forming both by peelable sealing with another film and seal-freezones. Pre-forming can be achieved, for example, by thermoforming a filmby means of thermoforming molds.

[0020] Films in the sense of the invention are deformable, in particularplastically deformable, if, when they are exposed to an external force(for example by an internal pressure building up in a chamber when thedevice is activated), they yield to this force while deforming, forexample by permanent expansion. Suitable films which can be deformed bythe activation of the device preferably do not have any appreciableelasticity and consequently have no appreciable recovery.

[0021] A film is expandable in the sense of the invention if it can bepermanently expanded or deformed by the internal pressure building upwhen the device is activated.

[0022] Since the volume of the second chamber increases only “whenrequired” by activation of the device, the invention makes possible aminimal pack volume for the substances to be stored and to be mixed.

[0023] Furthermore, the substances can be filled into the chambers ofthe device with virtually no inclusion of atmospheric oxygen or othergases in the dead volume, since the additional volume required in thesecond chamber for mixing is automatically provided when the firstsubstance is transferred from the first chamber into the second chamber.

[0024] The creation of a compressed gas cushion (air spring) in thesecond chamber by the transfer of the first substance from the firstchamber into the second chamber, which would force one of the substancesback into the first chamber, is consequently prevented to the greatestextent.

[0025] A similar effect can be achieved—albeit with high technicalexpenditure—by filling the device under vacuum. In this case, the volumenot filled by the substance (dead volume) during filling is replaced bya vacuum, which after sealing of the device and subsequent exposure ofthe device to atmospheric pressure leads to corresponding shrinkage ofthe zones of the volume that are under vacuum. By combining the twopossibilities, the dead volume can be reduced virtually completely.

[0026] The device is suitable in particular for storing, mixing anddispensing substances which are present in the device in differentvolumes.

[0027] To ensure that the substance with the smaller volume takes partsubstantially completely in the mixing operation and that instances ofmisapportionment are prevented during mixing, it is expedient to storethis substance in the second chamber and to carry out the mixing in thischamber. The substance with the greater volume is in this respectexpediently stored in the first chamber. In this way, a reproduciblemixing result that is virtually independent of the user is ensured whenthe substance with the greater volume is transferred from the firstchamber into the second chamber.

[0028] By bending the device in the zone between the chambers, thetransition zone or zones that can be selectively opened can be closedagain when required. Flowing back of the mixed substances into the otherchamber is then virtually impossible, so that the mixed substances canbe transferred into the dispensing zone by pressure being applied to theouter zone of the films forming the second chamber.

[0029] The volume of the first chamber usually lies in the range from0.01 to 100 ml, preferably in the range from 0.05 to 50 ml.

[0030] The volume of the second chamber is preferably less than or equalto the volume of the first chamber, at least before the activation ofthe device, and lies in the range from 0.001 to 100 ml, preferably inthe range from 0.01 to 25 ml.

[0031] A chamber has, for example, a diameter from 1 to 100 mm,preferably in the range from 5 to 50 mm. The total volume which can beapplied usually lies in the range from 0.011 to 200 ml, preferably therange from 0.06 to 75 ml.

[0032] To achieve the increase in volume of the second chamber essentialfor the invention, different embodiments are conceivable.

[0033] The increase in volume can be achieved, for example, by asubstantially concave formation of the base film and substantiallyconvex formation of the covering film (from the view of the productfilled into the chamber). The covering film is for this purpose likewisethermoformed somewhat in the area of the second chamber and connected tothe second film in such a way that the thermoformed zone can bulgeoutward when the device is activated.

[0034] To reduce the resistance with which the thermoformed film opposesthe pressure building up in the chamber when it is bulging outward, andto ensure a maximum increase in volume, the following method ofproduction has proven to be advantageous:

[0035] The covering film is firstly thermoformed and subsequentlyinverted, so that the indentation in the film is located on the sideopposite from the thermoformed mold. The material displacement occurringin the film during thermoforming, and the associated stress, are atleast partly retained during the inversion, so that the film is, as itwere, in a quasi prestressed state and can consequently be invertedoutward more easily upon activation. The covering film produced in thisway is finally sealed onto the likewise thermoformed base film. Theinverted indentation in the covering film and the indentation in thebase film in this case point in the same direction and form between themthe volume of the second chamber in the storing state.

[0036] The description of the form of a film as “concave” or “convex”does not, however, exclude the possibility of the film changing itscurvature characteristics, in particular in edge zones.

[0037] It is also conceivable to thermoform only the base film, to beprecise in a form which makes it possible for the film to bulge when thedevice is activated. Such a form can be achieved for example by theinitially convexly outward-bulged base film being at least partiallypressed in again. This form can, however, also be achieved in a singlestep by providing a corresponding mold. Consequently, a film which isdeformed in a more or less wave-shaped manner in cross section isobtained.

[0038] In a variant of this embodiment, the base film has, viewed incross section, a number of wave peaks and wave valleys, it beingpossible for the film to be sealed with the covering film in a peelablemanner in the area of a wave valley, so that the chamber is subdividedinto a number of compartments.

[0039] The device is consequently suitable, if appropriate, for storingand mixing more than two substances. The second substance, expedientlysealed in a peelable manner in the center of the second chamber, isinitially surrounded without direct contact, in a channel-like manner,by the first substance transferred from the first chamber into thesecond chamber when the device is activated. With increasing pressure onthe first chamber and transfer of an increasing amount of secondsubstance, the sealing seam in the area of the wave valley begins tocome apart, whereby the first substance begins to wet the secondsubstance.

[0040] A further possibility is for the second chamber to be sealed in apeelable manner in an edge zone or the two films forming the chamber tobe pressed one onto the other, lying flat, in this zone without sealingthem in a peelable manner in this zone. This edge zone is adjoined by anon-peelable sealing zone, which in the end, and in particular when thedevice is activated, seals off the chamber from the outside. Thisnon-peelable (firmly sealed) sealing zone is only interrupted by apeelable transition zone at the point at which the second chamber opensinto the dispensing zone and the connection between the first chamberand the second chamber is to be established. The increase in volume ofthe second chamber when the device is activated takes place by thecovering film allowing itself to be detached or lifting off from thebase film in this area.

[0041] It has been found that peelably sealed or unsealed edge zones mayhave a stronger recovering tendency after the increase in volume broughtabout by activating the device than films which are converted from aconvex form into a concave form upon activation.

[0042] An increase in volume of the second chamber can also be achieved,for example, by at least one of the films forming the second chamberbeing deformable or expandable, in particular plastically deformable.When the first substance is transferred into the second chamber, in thiscase the increase in volume takes place by the plastically deformablefilm allowing itself to expand, preferably without appreciable recovery.

[0043] The possibilities stated above can of course also be combinedwith one another.

[0044] The width of the peelably sealed edge zone can in principle beany width desired and depends on the desired increase in volume. A widthin the range from 0.1 to 40 mm, preferably from 0.5 to 20 mm, has provensuccessful.

[0045] The zones that can be selectively opened, or the peelably sealedzones, preferably open when a hydrostatic pressure in the range from 3to 300 N/cm², particularly preferably in the range from 15 to 150 N/cm²,is exerted by a flowable substance on this zone. The pressure to beapplied for opening the zones that can be selectively opened may varyfor each zone that can be selectively opened, depending on theembodiment. This makes possible a directed transfer of the substances tobe mixed into the respective chambers as far as the dispensing zone.

[0046] Depending on the embodiment and films used, slight changes ingeometry of the device may occur, in particular in the area of thesecond chamber, when the device is activated. If appropriate, one of thefilms forming the chamber bulges slightly outward as the pressureincreasingly builds up.

[0047] Preferably, the second chamber is also connected to thedispensing zone via a transition zone that can be selectively opened.This makes easier handling possible. The mixed composition can in thiscase be dispensed by exerting pressure on the second chamber, withoutfurther auxiliary means being necessary for opening the device.Expediently, when the flowable composition is being dispensed, thetransition zone to the first chamber is closed by bending it over.

[0048] Dispensing zone in the sense of the invention is to be understoodhere as meaning the zone of the device via which emptying of the mixedcomposition takes place.

[0049] The dispensing zone is preferably shaped in such a way thatdependable, uniform dispensing can be ensured.

[0050] In this respect, the introduction of flow barriers, as describedin DE 19 962 436 A, has proven successful.

[0051] Barriers of this type ensure that the composition is notspattered when it is dispensed.

[0052] By including flow barriers in the dispensing zone, the substanceis influenced when it flows out through the dispensing zone in such away that slow delivery from the dispensing zone is ensured at the mouthof the latter. Consequently, spattering of the substance caused byexerting high pressure on the second chamber when the transition zonesuddenly opens is also prevented. The increase in the flow resistance,and consequently the hindering of the outflow of the substance, can beachieved by extending the flow path around the barriers, if appropriatewith a change of direction, or by reducing the flow cross section bysealing points or sealing webs arranged in an offset manner.

[0053] Furthermore, an increase in the flow resistance can be achievedby a straight constriction of the flow cross section in the dispensingzone. In this case, a restriction by a factor of 1.5 to 5, preferably bya factor of 2, is envisaged. A device of this type is suitable inparticular whenever low-viscosity substances are to be dispensed withoutfurther auxiliary means in a targeted, easy manner without spilling.

[0054] Furthermore, the device may have a dispensing zone which isgeometrically arranged in such a way in relation to the transition zonethat the longitudinal axis of the dispensing zone does not run throughthe transition zone. In this case, the dispensing zone may have anenlarged volume, in particular in the part adjoining the transitionzone. It is particularly preferred if the dispensing zone is formed as apocket. In the case of this arrangement, it is of advantage that thesubstance is conveyed into the dispensing zone by pressure on thesubstance located in the chamber when the transition zone suddenlyopens. In said dispensing zone, the substance experiences a change indirection of the outflow direction as a result of the arrangement of thelongitudinal axis of the dispensing zone which does not intersect thetransition zone. On account of this change in direction, a slow deliveryfrom the dispensing zone is ensured at the mouth of the latter. If thedispensing zone is formed as a pocket, the substance suddenly flowingout is initially collected in this pocket. Then slow and directeddispensing is possible from this pocket.

[0055] To prevent the substances located in the second chamber after theactivation of the device from flowing back into the first chamber, itmay also be advantageous to fit a valve in the transition zone betweenthe two chambers.

[0056] A suitable valve is represented for example by a flexible film(referred to hereafter as valve film), which is fastened in thetransition zone between the two chambers, for example to the base film,and protrudes into the second chamber. The first substance can, asalready described, be transferred from the first chamber into the secondchamber. As soon as the first substance has been transferred completelyinto the second chamber through the now opened transition zone, thevalve film prevents flowing back of the substances located in the secondchamber, in that it blocks the transition zone.

[0057] Among the advantages provided by this embodiment is that thedevice does not need to be bent in the transition zone between the twochambers after activation to exclude the possibility of substanceflowing back into the first chamber. In the case of this embodiment, itis also not necessary for the films forming the second chamber to beplastically deformable.

[0058] For production reasons, it may be advantageous if the valve filmadditionally lines the first chamber completely or partly and, ifappropriate, reaches into the firmly sealed edge zone of the firstchamber. In this case, it may be adequate if the valve film adheres onits upper side to the base film only in the transition zone.

[0059] The transition zone that can be selectively opened, incombination with the valve film can, for example, also be realized inthe following way: the valve film is, for example, connected to thecovering film in the area of the first and second chambers and in thetransition zone. In the area of the first chamber, in the vicinity ofthe transition zone that can be selectively opened to the secondchamber, the valve film has an opening which has, for example, beenpunched out from the valve film. The valve film has, furthermore, in thezone of the second chamber a tab or tongue, which can be formed, forexample, by punching or cutting out a corresponding shape from the valvefilm. The residual zone of the valve film detached in the zone of thetab is in this case not removed, but remains in the zone of the secondchamber. The valve film is sealed in a peelable manner with the coveringfilm, preferably only in the transition zone. When the device isactivated, the substance is transferred from the first chamber into thesecond chamber through the opening in the valve film via the transitionzone that can be selectively opened, with the tab of the valve filmlifting up. As soon as substantially the entire amount of the firstsubstance has been transferred into the second chamber, the tab ispressed against the covering film in the area of the second chamber, orinto the existing punched clearance, by the internal pressure buildingup in the second chamber and pressure relief of the first chamber, andin this way prevents the flowing back of the substance into the firstchamber.

[0060] In a further embodiment, a third chamber, which is filled with athird substance, may be located in the transition zone that can beselectively opened, between the first chamber and the second chamber.When the device is activated, in this case firstly the third chamber isopened and the first substance emerging from the first chamber is unitedwith the third substance, located in the third chamber, before itfinally enters the second chamber, in which the actual mixing operationtakes place.

[0061] This arrangement is suitable in particular for intensive mixingof identical or different liquids, which are located in the first andsecond chambers, with for example a powder, which is located in thethird chamber lying in between. The third chamber can be flushed throughparticularly intensively by repeated, alternating exertion of pressureon the first chamber or second chamber and the substances locatedtherein. In this case, a volume reservoir located in the first and/orsecond chamber is of advantage.

[0062] The device is usually a disposable pack (unit dose). The deviceis suitable for storing and dispensing all substances for whichreproducible mixing and apportioning, to a great extent independently ofthe user, is required.

[0063] In particular, the device has proven successful in the area ofhuman and veterinary medicine and in the dental sector.

[0064] Substances to be stored are usually liquids, pastes and/orsolids. The solids may in this case be in the form of powder, tablets orgranules.

[0065] The device is preferably suitable for storing, mixing anddispensing compositions chosen from: human and veterinary medicaments,wound cleaning agents, dental products, adhesives, impression materials,paints, in particular two-pack paints, foods to be stored separately ortheir constituents.

[0066] The device substantially comprises a first base or lower film anda second covering or upper film, which for their part may be formed asmultilayer films.

[0067] Depending on the embodiment which is chosen to make possible theincrease in volume essential for the invention, at least one of thefilms is plastically deformable, preferably thermoformable whiledeforming.

[0068] Preferably used as films are those which have adequate diffusionimpermeability.

[0069] Depending on the nature of the substance to be stored, the filmsshould also be resistant to aggressive substances, for example causticsubstances and/or substances having the properties of solvents.

[0070] Depending on the application area and the desired deformability,the films are stretched or are in an unstretched state before theactivation of the device.

[0071] The film constituents may be chosen from plastic films, metalfoils and ceramic sheets.

[0072] Conceivable as plastic films are, for example: PE, PP, PTFE, PET,PA, PBT, PVC, EVA, PVF (polyvinyl fluoride).

[0073] Conceivable as metal foils are, for example: Al, Sn, Au, Ag, Fe,Pb.

[0074] Ceramic sheets are to be understood as meaning films which have,for example, a layer containing SiOx.

[0075] The film may, in principle, be of any desired construction and isbased, inter alia, on the nature of the substances to be stored.

[0076] A film construction with the sequence from the outside inward ofPET, Al, PET, PE or PP, Al, PET, PE, if appropriate also without a PETfilm as a middle film, has proven to be advantageous.

[0077] With the exception of the zones forming the chambers, the filmsare preferably connected to one another in surface-area contact.

[0078] The connection of the first film to the second film may takeplace, for example, by hot-sealing, cold-sealing, adhesive bondingand/or ultrasonic welding with sonotrodes.

[0079] A multilayer construction of the first and second films can beachieved by laminating, calendering, laminating of various layerscomprising single films, if appropriate also by vapor-depositing, forexample with metals.

[0080] To ensure that the substances which are introduced into thedevice and can be applied are protected from incident light, forexample, the films are preferably configured in such a way that, in anarea surrounding the chamber, they are connected to one another by twospaced-apart sealing seams.

[0081] The device can in principle be of any desired form, but ispreferably adapted to the nature of the substances stored.

[0082] The chambers are preferably formed such that they are round(circular or oval) but, if appropriate, also angular (square,rectangular or triangular).

[0083] The transition zone is designed such that, in the storing state,it forms a sealed closure, both between the two chambers and withrespect to the zone via which the composition is to be dispensed.

[0084] The transition zone that can be selectively opened, or thepredetermined breaking point, can be achieved for example bycold-sealing, hot-sealing, ultrasonic welding or adhesive bonding, adifferent energy input, preferably lower energy input, taking place inthe case of hot-sealing in comparison with the other sealing zones. Thiscan be controlled by means of temperature, pressure and/or holding time.

[0085] Another possibility is to introduce adhesion-reducing foreignparticles, such as punched pieces of peeling film or spots of hot-meltadhesive, between the first film and the second film in the area of thepredetermined breaking point. In this case, firmly sealing films arepreferably used as the upper and lower films.

[0086] The dispensing zone is preferably formed such that it is opentoward one side, i.e. in pocket-like, and if appropriate formed suchthat a dispensing instrument or an applicator can even be introduced inthe storing state. The dispensing zone may also serve as an applicationdevice itself if there is a correspondingly small diameter of theopening toward the outside, for example in the form of a cannula.

[0087] The separation between the chamber or chambers and the dispensingzone is configured with respect to the distance and also with respect tothe strength of the adhesive bond such that there is a furtherpredetermined breaking point.

[0088] The possibly present application instrument is preferablydesigned like a brush or a swab. An application instrument with aspherical tip bearing bristles or brush hairs has proven to befavorable. Furthermore, pipettes, cotton sticks, sponges, spatulas orspray heads sealed into the dispensing zone may also be used as anapplication instrument or as application devices.

[0089] Furthermore, it is favorable when using an application instrumentif the dispensing zone is to a great extent sealed off from the outsideby the application instrument.

[0090] A dispensing instrument located in the dispensing zone or onlyintroduced into it at this or a later point in time is wetted when thedevice is activated and can subsequently be used for applying thereleased substance.

[0091] It is also conceivable for the application instrument to be movedin the direction of the second chamber, in order to release thetransition zone that can be selectively opened. This likewise results inthe dispensing instrument being wetted.

[0092] If repeated application of the released substance is necessary,the application instrument can be reinserted into the pocket.

[0093] The dispensing zone or the application instrument is preferablydesigned in such a way that, when it is reinserted, wetting of the outerportion of the application instrument does not take place.

[0094] This may happen, for example, by a channel-shaped formation ofthe dispensing zone and a matching formation of the applicationinstrument.

[0095] It is also conceivable for one of the films to be designed in adish-shaped or well-shaped manner in the dispensing zone, into which thesubstance is conveyed for repeated wetting of the application instrumentwithout wetting the shaft by squeezing out the chamber in a way similarto in the case of tubes.

[0096] The device can be produced, for example, by the following method:

[0097] a) provision of a first film,

[0098] b) partial thermoforming of the first film, thereby forming twochambers,

[0099] c) filling of the two chambers with two substances to be mixed,

[0100] d) application of a second film,

[0101] e) connecting of the second film to the first film to a greatextent in surface-area contact, leaving the chambers free and forming atransition zone that can be selectively opened between the two chambersand in the dispensing zone.

[0102] Depending on which embodiment is chosen for the increase involume of the second chamber, further steps are to be applied.

[0103] Either the first film is sealed with the second film only in apeelable manner in the edge zone of the second chamber.

[0104] Alternatively, the second film is thermoformed in the area of thesecond chamber before application (step d)) and subsequently appliedwith the curvature in the direction of the thermoformed area of thefirst film from step b) and sealed, with a concave-convex chamber beingformed.

[0105] Exemplary embodiments of the invention are explained in moredetail below on the basis of the drawings. The representations in dashedlines show the device after activation.

[0106]FIG. 1 shows one possible embodiment of the device in crosssection.

[0107]FIG. 2 shows a further embodiment of the device in cross section.

[0108]FIG. 3 shows a third possible embodiment of the device in crosssection.

[0109]FIG. 4 shows the embodiment according to FIG. 1 in plan view.

[0110]FIG. 5 shows one possible embodiment of the device, including avalve, in cross section.

[0111] The device according to FIG. 1 has a base film (1) and a coveringfilm (2). In the area (3), the two films are sealed to each other in apeelable manner, whereby a transition zone that can be selectivelyopened is formed between the two chambers (5) and (6). In FIG. 1, thedispensing zone (4) also has a transition zone that can be selectivelyopened. In the chambers (5) and (6) there are two substances (A) and (B)to be mixed. The volume of the second chamber (6) can be enlarged assoon as the device is activated by exerting external pressure on thefirst chamber (5). In this respect, the base film (1) is curvedconcavely outward in the zone of the second chamber (6) and the coveringfilm (2) is curved or pre-formed convexly inward.

[0112] After activation, the substance (A) from the first chamber (5) islocated together with the substance (B) in the second chamber (6). Then,like the base film (1), the covering film (2) likewise has a concavelyoutward-curved form (dashed line in FIG. 1).

[0113]FIG. 2 shows a further possible embodiment for the device in crosssection. The increase in volume of the second chamber (5) can beachieved by pre-forming of the base film (2) in the zone of the secondchamber (6) with wave peaks (9) and wave valleys (10). Depending on theembodiment, the base film 1 may be sealed in a peelable manner to thecovering film (2) not only in the transition zone (3) but additionallyat least in the zone of a wave valley (10).

[0114] After activation, both substances (A) and (B) are located in thesecond chamber (6), the volume of which has been increased by bulging ofthe wave valley (10) into a form which, overall, is to a great extentconcave (dashed line in FIG. 2).

[0115]FIG. 3 shows a further possible embodiment of the device in crosssection. In the edge zone (11) of the second chamber (6), the base film(1) and the covering film (2) are pre-formed such that they can beseparated from each other. This pre-forming can be achieved, forexample, by peelable sealing of the films in this area or by the filmbeing pressed one onto the other, lying flat, in this area, withoutbeing sealed in a peelable manner in this area.

[0116] After activation, the base film (1) has been separated or liftedoff from the covering film (2) in the edge zone (11) of the secondchamber (6) (dashed line in FIG. 3). Both substances (A) and (B) arethen located in the second chamber (6). For opening the device, afterbending of the device in the transition zone (3) and subsequent exertionof pressure on the second chamber (6), the resistance caused by thetransition zone that can be selectively opened is overcome in thedispensing zone.

[0117]FIG. 4 shows the device based on FIG. 1 in plan view. Thedispensing zone (4) has flow barriers or is formed in a meanderingmanner in the area (13). This prevents spattering when the compositionis dispensed from the device.

[0118] In FIG. 5, there is in the first chamber (5) and in thetransition zone (3) that can be selectively opened a further film (12),which is fastened to the base film (1) and protrudes into the secondchamber (6), the film (12) not necessarily being thermoformed in thearea of the second chamber. This film (12) performs a valve function,which prevents the substances (A) and (B) that are located in the secondchamber (6) after activation of the device from being able to returnagain into the first chamber (5) when, to dispense the compositioncomprising the substances (A) and (B), pressure is exerted on the secondchamber (6) in order to open the transition zone that can be selectivelyopened to the outside in the dispensing zone. In this embodiment, thetransition zone (3) that can be selectively opened is located betweenthe valve film (12) and the covering film (2).

[0119] The dashed representation in FIG. 5 shows the device afteractivation. The covering film (2) has bulged outward as a result of thebuilt-up internal pressure in the second chamber (6). This deforming ofthe covering film (2) leads to an increase in volume of the secondchamber (6) and makes it possible for the two substances (A) and (B) tobe received. The valve film (12) is in this case pressed against thecovering film and thereby prevents the mixture from flowing back intothe first chamber (5) without the device having to be bent in thetransition zone between the two chambers.

[0120] Another meaningful application for the device is in theproduction of packs which can be sterilized, for example by γ rays orheat. As a result of the pre-forming according to the invention of atleast one of the films, the substance or substances stored in the sealeddevice can be sterilized without any problem by the means mentionedabove even if, for example due to the increase in temperature, thiscauses outgassing of the stored substances, without the device itselfbeing activated or the transition zones that can be selectively openedand that adjoin the chamber or chambers being opened. This type of usemay also be employed in the case of devices which have only one chamberfor storing a substance.

1. A device, comprising a first and a second film, a dispensing zone, afirst chamber, containing a first substance, and a second chamber,containing a second substance, the chambers being connectable to eachother via a transition zone that can be selectively opened, at least oneof the films being thermoformed in the area of the chambers, and atleast one of the films being pre-formed or plastically deformable in thearea of the second chamber in such a way that, after activation of thedevice, with the transition zone being opened, the first substance canbe transferred to a great extent completely into the second chamber,with an increase in volume of said second chamber, without anyappreciable flowing back of the mixture into the first chamberoccurring.
 2. The device as claimed in claim 1, the film beingconcavely-convexly deformed in the area of the second chamber.
 3. Thedevice as claimed in claim 1, at least one of the films having in thearea of the second chamber a form which can be obtained by at leastpartially forming a depression into an initially concavely formedsurface.
 4. The device as claimed in claim 3, the one film reaching asfar as the other film in the area of the recess and being sealed in apeelable manner at the point of contact with said other film.
 5. Thedevice as claimed in claim 1, the films forming the chamber beingpre-formed such that they can be separated from each other, at least inan edge zone of the second chamber.
 6. The device as claimed in claim 1,at least one film being expandable in the area of the second chamber. 7.The device as claimed in one of the preceding claims, the second chamberbeing connectable to the dispensing zone via a transition zone that canbe selectively opened.
 8. The device as claimed in one of the precedingclaims, a third chamber being located between the first chamber and thesecond chamber in the transition zone that can be selectively opened. 9.The device as claimed in one of the preceding claims, a third film,which protrudes into the second chamber, being attached to one of thefilms forming the chambers in the transition zone between the twochambers.
 10. The device as claimed in one of the preceding claims, thechambers having different volumes before activation.
 11. The device asclaimed in one of the preceding claims, comprising an applicator. 12.The device as claimed in claim 11, the applicator being located in thedispensing zone.
 13. The device as claimed in one of the precedingclaims, the first substance being flowable and the second substancebeing solid.
 14. The device as claimed in one of the preceding claims,flow barriers being located in the dispensing zone.
 15. The device asclaimed in one of the preceding. Claims, the transition zone that can beselectively opened allowing itself to be opened by exposure to ahydrostatic pressure in the range from 3 to 300 N/cm².
 16. The use ofthe device as claimed in one of the preceding claims for storing, mixingand/or dispensing flowable compositions.
 17. The use as claimed in claim16, the flowable compositions being chosen from: human and veterinarymedicaments, wound cleaning agents, dental products, adhesives,impression materials, paints, foods.
 18. A method for producing a deviceas claimed in one of claims 1 to 15, comprising the steps: a) provisionof a first film, b) partial thermoforming of the first film, therebyforming two chambers, c) filling of the two chambers with two substancesto be mixed, d) application of a second film, e) connecting of thesecond film to the first film to a great extent in surface-area contact,leaving the chambers free and forming a transition zone that can beselectively opened between the two chambers.
 19. The method as claimedin claim 18, the second film being pre-formed in a convex or wave-shapedmanner in the area of the second chamber before step d).
 20. The methodas claimed in claim 18, a third film being connected to the first filmin the transition zone before step d).